Baxter DIANEAL Low Calcium PD Solution

Description:  DIANEAL Low Calcium PD Solution, Luer, Single Bag (AMBU-FLEX II Container); Dextrose 1.5%; Fill Volume 5000mL; Container Size 6000mL, Product Code: L5B4826, Lot Number: C886820

Baxter received complains for one (1) lot (lot C886820) of Dianeal Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose in which the blue frangible is cracking prematurely.  This could allow the fluid to leak from the luer connector during the set-up process.

Hazard:  With leakage, there may be a loss of fluid from the bag, a delay in therapy, and a potential for contamination of the bag contents and/or fluid path.  If a contaminated bag is used, it could possibly lead to infection.  There have been no injuries reported for this issue.

Remedy:  Baxter is requesting that you take the following actions:

1.       Locate and separate the affected product, Code L5B4825, Lot Number C886820, from the supplies.  The product code and lot number can be found on the individual solution bag and shipping carton.

2.       To arrange for the return of your affected product and receive replacement product, please contact Baxter Home Care Services at 1-800-284-4060 between the hours of 7:00am and 6:00pm Central Time.  Please have your Baxter eight-digit ship-to-account number ready when calling.

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